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Cardiovascular

28,927 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
ACS RX ALPHA(TM) .014 CORONARY DILATATION CATHETER (P810046/S093)Advanced Cardiovascular Systems, Inc.1990-11-14
1MER, ED. LABS. PTCA (P850021/S010)Abbott Vascular, Inc.1990-11-14
2.5 HOLIUM/ND:YAG SPECTRAPROBE FLEX CATHETER (P870043/S011)Trimedyne, Inc.1990-11-14
GLIDER AND COATED GLIDER CATHETERS (P840040/S017)Boston Scientific Corp1990-11-08
CORDIS ORION STEERABLE PTCA BALLOON CATHETER (P890032/S004)Cordis Corp.1990-11-08
MODELS 5345 & 5342 TEMPORARY PULSE GENERATORS (P820003/S050)Medtronic Cardiac Rhythm Disease Management1990-11-06
ACS PTCA CATHETERS (P810046/S084)Advanced Cardiovascular Systems, Inc.1990-11-01
CPI MODEL 6826 & 6828 AICD LEAD STYLET (P830060/S023)Boston Scientific1990-10-31
MODEL K (UNIPOLAR) & M (BIPOLAR) ENDOCARDIAL LEADS (P870054/S009)Cook Pacemaker Corp.1990-10-31
MEDTRONIC MICRO MINIX PULSE GENERATOR MODEL 8360 (P850051/S025)Medtronic, Inc.1990-10-30
META MV MODEL 1202 CARDIAC PACING SYSTEM (P880038/S016)St. Jude Medical, Inc.1990-10-22
META MV MODEL 1202 CARDIAC PACING SYSTEM (P880038/S014)St. Jude Medical, Inc.1990-10-15
LEX MODEL 8220E SINGLE CHAMBER PULSE GENERATOR (P820018/S045)St. Jude Medical, Inc.1990-10-15
AUTIMA PACING SYSTEM (META DDD MODEL 1230) (P820018/S046)St. Jude Medical, Inc.1990-10-15
ACS PTCA CATHETERS (P810046/S080)Advanced Cardiovascular Systems, Inc.1990-10-10
ACS RX(R) - .014 CORONARY DILATATION CATHETER (P810046/S083)Advanced Cardiovascular Systems, Inc.1990-10-05
PRIME{TM} MODEL 6520, 6525, 6530 AND 6535 (P870021/S004)Medtronic, Inc.1990-10-04
ACS(R) RX PERFUSION(TM) CORONARY DILATATION CATH. (P810046/S079)Advanced Cardiovascular Systems, Inc.1990-10-04
CAPSURE(R)SP PACING LEADS (P830061/S013)Medtronic Cardiac Rhythm Disease Management1990-09-27
SLIDER 014 & SLIDER 018 BIFURCATED CATHETERS (P840040/S015)Boston Scientific Corp1990-09-27
MICROSOFTRAC (R) PTCA CATHETER (P880027/S008)Boston Scientific1990-09-27
MODEL 5024 TRANSVENOUS PACING LEAD (P850089/S013)Medtronic Cardiac Rhythm Disease Management1990-09-27
CAPSURE(R) PACING LEADS (P850089/S014)Medtronic Cardiac Rhythm Disease Management1990-09-27
CORONARY BALLOON DILATATION CATHETER (P880055)Boston Scientific Corp1990-09-26
MASTRO SAVVI SERIES 300 VDD PACING SYSTEM (P890039)Cardiac Control Systems, Inc.1990-09-25
ACS(R) STACK PERFUSION(R) DISTAL FLOW COR. DIL. CA (P810046/S089)Advanced Cardiovascular Systems, Inc.1990-09-21
MODEL AT-103(SIZES 19-31MM) & MT-103(SIZES 19-33MM (P810002/S019)ABBOTT MEDICAL1990-09-21
META MV MODEL 1202 CARDIAC PACING SYSTEM (P880038/S015)St. Jude Medical, Inc.1990-09-19
MANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER (P880065)Boston Scientific Corp1990-09-19
VENTAK(R) MODEL 1555 PULSE GENERATOR (P830060/S020)Boston Scientific1990-09-17
SCIMED PTCA DILATATION CATHETER (P860019/S032)Scimed Life Systems, Inc.1990-09-17
AURORA MODELS 6291 & 6292 MULTIPROGRAM. DDD P. GEN (P820018/S042)St. Jude Medical, Inc.1990-09-17
SIMPSON CORONARY ATHEROCATH(TM) (P890043)Abbott Vascular1990-09-14
ACS(R) STACK PERFUSION(R) CORONARY DILATATION CATH (P810046/S078)Advanced Cardiovascular Systems, Inc.1990-09-14
CORDIS ORION STEERABLE PTCA BALLOON CATHETER (P890032/S003)Cordis Corp.1990-09-14
VENTAK(R) MODEL 1555 PULSE GENERATOR (P830060/S019)Boston Scientific1990-09-13
0CIMED PTCA DILATATION CATHETER (P860019/S026)Scimed Life Systems, Inc.1990-09-12
8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER (P870043/S007)Trimedyne, Inc.1990-09-12
ACS CORONARY DILATATION CATHETERS (P810046/S073)Advanced Cardiovascular Systems, Inc.1990-09-12
DARDIK BIOGRAFT FOR PERIPHERAL & AV ACCESS USE (P780002/S008)Synovis Surgical Innovations1990-09-11
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S017)Trimedyne, Inc.1990-09-11
MODELS P15-020,15-025,15-030,15-035, & P15-040 (P880027/S006)Boston Scientific1990-09-10
META DDD MODEL 1230 PACER (P880038/S011)St. Jude Medical, Inc.1990-09-10
MODEL 446 & 447 VISTA T,MODEL 940 & 941 VISTA DDD (P840068/S013)Boston Scientific1990-08-31
AURORA MODELS 6291 & 6292 MULTIPROGRAM. DDD P. GEN (P820018/S040)St. Jude Medical, Inc.1990-08-29
MICROSOFTRAC (R) PTCA CATHETER (P880027/S007)Boston Scientific1990-08-29
MODEL 5023M UNIPOLAR PACING LEAD (P850089/S012)Medtronic Cardiac Rhythm Disease Management1990-08-28
ACS RX ALPHA(TM) .014 CORONARY DILATATION CATHETER (P810046/S081)Advanced Cardiovascular Systems, Inc.1990-08-23
MODEL 446 & 447 VISTA T,MODEL 940 & 941 VISTA DDD (P840068/S014)Boston Scientific1990-08-23
AURORA MODELS 6291 & 6292 MULTIPROGRAM. DDD P. GEN (P820018/S043)St. Jude Medical, Inc.1990-08-23
ACS(R) STACK PERFUSION(R) CORONARY DILATATION CATH (P810046/S076)Advanced Cardiovascular Systems, Inc.1990-08-23
ACS(R) STACK 40(TM) CORONARY DILATATION CATHETER (P810046/S075)Advanced Cardiovascular Systems, Inc.1990-08-23
CORDIS ORION STEERABLE PTCA BALL. CATH. 1.5 CM TIP (P890032/S006)Cordis Corp.1990-08-15
MICROSOFTRAC TM (PTCA) CATHETER (P880027/S005)Boston Scientific1990-08-10
MODEL 283 PULSE GENERATOR MODEL 370 PROGRAMMER (P830045/S026)St. Jude Medical, Inc.1990-07-26
META-MV,PACING SYSTEM (P880038/S006)St. Jude Medical, Inc.1990-07-25
MODEL 9710E ENHEANCED PROGRAMMING SYSTEM (P820003/S049)Medtronic Cardiac Rhythm Disease Management1990-07-20
SCIMED PTCA DILATATION CATHETER (P860019/S025)Scimed Life Systems, Inc.1990-07-20
MICROVEL(R) WITH HEMASHIELD (P840029/S002)Maquet Cardiovascular, LLC1990-07-18
NOVA II-281-05,282--04,QUANTUM II,253-25,254-30 (P830026/S044)Boston Scientific1990-07-18
LEGEND/LEGEND ST PULSE GENERATORS : NEW IC (P850051/S026)Medtronic, Inc.1990-07-17
HARTZLER EXCEL II TM CORONARY DILATATION CATHETER (P810046/S070)Advanced Cardiovascular Systems, Inc.1990-07-16
SCIMED PTCA DILATATION CATHETER (P860019/S029)Scimed Life Systems, Inc.1990-07-10
VERSATRAX MODEL 7000 PULSE GENERATOR (P820003/S051)Medtronic Cardiac Rhythm Disease Management1990-07-05
MODEL 9710E ENHEANCED PROGRAMMING SYSTEM (P820003/S048)Medtronic Cardiac Rhythm Disease Management1990-06-28
TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE (P860042/S024)Trimedyne, Inc.1990-06-25
8 ECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER (P870043/S010)Trimedyne, Inc.1990-06-25
VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM (P870036/S007)Medtronics Interventional Vascular1990-06-25
AMER, ED. LABS. PTCA (P850021/S009)Abbott Vascular, Inc.1990-06-22
MODEL Q (UNIPOLAR) & R (BIPOLAR) ENDOCARDIAL LEADS (P870054/S010)Cook Pacemaker Corp.1990-06-19
ACS(R) STACK PERFUSION(R) CORONARY DIL. CATHETER (P810046/S074)Advanced Cardiovascular Systems, Inc.1990-06-19
SOFTWARE RELEASE NUMBER 2.4 4.31 (P820076/S009)Biotronik, Inc.1990-06-13
SYNCHRONY II MODELS 2022T & 2023M - 2002T & 2003M (P880086/S004)ABBOTT MEDICAL1990-06-13
MODELS 940 & 941 VISTA DDD GEN. & MODEL 2050 MODUL (P840068/S008)Boston Scientific1990-06-13
CETA DDD MODEL 1230 PACER (P820018/S036)St. Jude Medical, Inc.1990-06-12
MICROSOFTRAC TM (PTCA) CATHETER (P880027/S004)Boston Scientific1990-06-11
SENSOLOG III MODEL 2033B & DIALOG II MODEL 2037B (P880006/S007)St. Jude Medical, Inc.1990-05-30
COSMOS, NOVA, NOVA II, & QUANTUM II (P830026/S042)Boston Scientific1990-05-30
COSMOS II(R) PULSE GENERATORS MODEL 283-03, 284-05 (P830026/S043)Boston Scientific1990-05-30
RX2000(TM) GRAPHICS PROGRAMMER-MODEL 522-06 (P830026/S041)Boston Scientific1990-05-30
ACS RX ALPHA PRIME CORONARY DILATATION CATHETER (P810046/S071)Advanced Cardiovascular Systems, Inc.1990-05-30
RX2000(TM) GRAPHICS PROGRAM MODULE (P830026/S040)Boston Scientific1990-05-30
MICROSOFTRAC TM (PTCA) CATHETER (P880027/S003)Boston Scientific1990-05-25
MODEL 446 & 447 VISTA T PU.GEN. MODEL 2046 SOF.MOD (P840068/S010)Boston Scientific1990-05-23
MAESTRO SERIES 500 P.G.& MODEL 1006 PACEMAKER PROG (P860027/S005)Cardiac Control Systems, Inc.1990-05-22
SCIMED PTCA DILATATION CATHETER (P860019/S028)Scimed Life Systems, Inc.1990-05-16
AURORA MODELS 6291 & 6292 MULTIPROGRAM. DDD P. GEN (P820018/S044)St. Jude Medical, Inc.1990-05-09
GEMINI(R) THETA MODEL 415A CARDIAC PACER (P830007/S032)Telectronics Pacing Systems, Inc.1990-05-09
SEQUICOR SERIES PULSE GEN. MODELS 233F,233G,& 240G (P820014/S044)Telectronics Pacing Systems, Inc.1990-05-09
META MV MODEL 1202 & 1202 PULSE GENERATORS (P880038/S012)St. Jude Medical, Inc.1990-05-09
MODEL 3003 PROGRAMMER MODEL 3036B FUNCTION PACK (P880086/S001)ABBOTT MEDICAL1990-05-04
MODEL 3033C FUCTION PACT USE W/MODEL 3000 PROGRAMM (P830045/S022)St. Jude Medical, Inc.1990-05-04
VENTAK 1550 PULSE GENERATOR (P830060/S015)Boston Scientific1990-05-04
MODEL283 PULSE GENERATOR & MODEL 370/375 SUPPORT S (P830045/S021)St. Jude Medical, Inc.1990-05-04
SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMM (P880006/S004)St. Jude Medical, Inc.1990-05-04
MODEL 3033C FUNCTION PACT (P880086/S003)ABBOTT MEDICAL1990-05-04
ANGIOPLASTY (PTCA) DILATATION CATHETERS (P890032/S001)Cordis Corp.1990-04-30
AMER, ED. LABS. PTCA (P850021/S008)Abbott Vascular, Inc.1990-04-30
ACS HARTZLER ACX II CORONARY DILATATION BALLOON CA (P810046/S065)Advanced Cardiovascular Systems, Inc.1990-04-24
ACS RX ALPHA CORONARY DILATATION CATHETER (P810046/S067)Advanced Cardiovascular Systems, Inc.1990-04-20
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